Below are some PDF files that can be found on the TGA website. It is a requirement of your course to know how to research these documents and present your findings in an info graphic suitable to use for advertising in social media or websites.
Assignment - Create a graphic promoting the therapeutic benefits of essential oils, as described by the TGA Framework.
Useful resources; Canva, Shutterstock, Picmonkey.
Public Summary
Summary for ARTG Entry: XXXXXXXXXXYoung Living peppermint essential oil
ARTG entry for Medicine Listed
Sponsor Young Living Essential Oils (Australasia) Pty Ltd
Postal Address PO Box 548, SUMNER PARK BC, QLD, 4074
Australia
ARTG Start Date 22/11/2019
Product Category Medicine
Status Active
Approval Area Listed Medicines
Conditions
The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine, (b)
Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is sub-contracted
to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be kept.
The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records to the
Complementary Medicines Branch, Therapeutic Goods Administration, upon request.
The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted in
elation to the inclusion of the medicine in the Register.
The sponsor shall not supply the listed medicine after the expiry date of the goods.
Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine outside
Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National Manager
Therapeutic Goods Administration, immediately the action or information is known to the sponsor.
Products
1 . Young Living peppermint essential oil
Product Type Single Medicine Product Effective Date 30/04/2020
Permitted Indications
Traditionally used in Aromatherapy to decrease
educe
elieve toothache
Traditionally used in Aromatherapy to analgesic/Anodyne
elieve pain
Traditionally used in Aromatherapy to antipyretic/fe
ifuge
elieve mild feve
educe body temperature
ody cooling
Traditionally used in Aromatherapy to decrease
educe
elieve mild rheumatic aches and pains
Traditionally used in Aromatherapy to decrease
educe
elieve loss of appetite
Traditionally used in Aromatherapy to maintain/support healthy appetite
Traditionally used in Aromatherapy to reduce occu
ence of excess intestinal wind/gas
Traditionally used in Aromatherapy to decrease
educe
elieve colic (wind/gas pain)
Traditionally used in Aromatherapy to decrease
educe
elieve flatulence/carminative
Traditionally used in Aromatherapy to helps reduce occu
ence of symptoms of indigestion/dyspepsia
Traditionally used in Aromatherapy to decrease
educe
elieve symptoms of indigestion/dyspepsia
Traditionally used in Aromatherapy to helps enhance/improve/promote/increase bile secretion/flow
Traditionally used in Aromatherapy to decrease
educe
elieve symptoms of stomach upsets
Traditionally used in Aromatherapy to decrease
educe
elieve nausea
Traditionally used in Aromatherapy to antispasmodic/spasmolytic
Traditionally used in Aromatherapy to decrease
educe
elieve headache symptoms
Traditionally used in Aromatherapy to decrease
educe
elieve mild migraine symptoms
Traditionally used in Aromatherapy to decrease
educe duration of mild migraine
Traditionally used in Aromatherapy to decrease
educe
elieve menstruation pain/dysmeno
hoea
Traditionally used in Aromatherapy to decrease
educe
elieve menstruation pain/dysmeno
hoea
Traditionally used in Aromatherapy to antitussive/cough suppressant
Traditionally used in Aromatherapy to decrease
educe
elieve cough
Indication Requirements
Product presentation must not imply or refer to eating disorders.
Product presentation must only refer to mild migraine.
Public Sum
m
ary
Page 1 of 2 Produced at XXXXXXXXXXat 07:47:22 AEST
This is not an ARTG Certificate document.
The onus is on the reader to verify the cu
ent accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Product presentation must only refer to mild rheumatic aches/pains.
Label statement: If symptoms persist, talk to your health professional.
Label statement: Adults only, OR Not to be used in children under 2 years of age without medical advice (or words to that effect).
Product presentation must not imply or refer to serious musculoskeletal or neurological conditions.
Product presentation must not imply or refer to gastro oesophageal reflux disease.
Label statement: Not to be used in children under 5 years.
Product presentation must not imply or refer to serious forms of respiratory disorders/diseases, such as: asthma, pneumonia, COAD, COPD, influenza.
Product presentation must not imply or refer to bone disease or disorders e.g. rheumatoid arthritis, juvenile arthritis, debilitating osteoarthritis, osteoporosis.
Note: this requirement is not intended to apply where the indications refe
ing to osteoporosis specified in column 2 of Table 2 of this instrument are also
used.
Standard Indications
No Standard Indications included on Record
Specific Indications
No Specific Indications included on Record
Warnings
No Warnings included on Record
Additional Product information
Container information
Type Material Life Time Temperature Closure Conditions
Bottle Not recorded Not recorded Not recorded Not recorded Not recorded
Pack Size/Poison information
Pack Size Poison Schedule
Components
1 . Formulation 1
Dosage Form Liquids
Route of Administration Inhalation
Topical
Visual Identification
Active Ingredients
Peppermint Oil 1 mL/mL
Equivalent: menthol 390 mg/g
© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth. Further details can be found at http:
www.tga.gov.au/about/website-copyright.htm.
Public Sum
m
ary
Page 2 of 2 Produced at XXXXXXXXXXat 07:47:22 AEST
This is not an ARTG Certificate document.
The onus is on the reader to verify the cu
ent accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
http:
www.tga.gov.au/about/website-copyright.htm